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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00365248
Other study ID # TC-019-IN
Secondary ID 2004-005028-42
Status Completed
Phase Phase 3
First received August 16, 2006
Last updated May 4, 2012
Start date October 2005
Est. completion date May 2008

Study information

Verified date July 2008
Source Nycomed
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

The overall objective is to assess the haemostatic efficacy and safety of TachoSil for control of local bleeding in paediatric patients undergoing surgical resection of the liver with our without segmental liver transplantation.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Years
Eligibility Inclusion criteria:

1. Has the parent(s)/legal guardian given informed consent according to local requirements before any trial related activities?

2. Is the child above 4 weeks and below 6 years of age?

3. Has at least segmental resection (anatomical/non-anatomical) of the liver and primary haemostatic treatment been performed? or Has resection of the liver and placement of a segmental liver graft and primary haemostatic treatment been performed?

4. Is only minor, i.e. oozing, or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?

All inclusion criteria must be answered "yes" for a child to participate in the study.

Exclusion criteria:

1. Was the child retransplanted or had liver transplantation in combination with other organs?

2. Was there anamnestic or laboratory evidence of congenital coagulation disorders including Haemophilia A or B and von Willebrand disease?

3. Has the child a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?

4. Has the child fulminant hepatic failure, portal vein thrombosis or anamnestic or clinical evidence of cirrhotic condition of the liver, including cirrhosis due to genetic deficiency of a1 - Antitrypsin?

5. Did the child undergo an emergency operation?

6. Does the child participate in another clinical trial during the intra-operative phase?

7. Has any serious surgical complication occurred?

8. Has any fibrin glue haemostatic (including TachoSil ® ) been used on the target wound before the planned application of TachoSil ® ? To participate in the study all exclusion criteria must be answered "No" for a child having segmental resection. For a child having total hepatectomy and placement of a segmental liver transplant criteria 4 and 5 can be answered "Yes".

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fibrinogen human (TachoSil)
Resection of the liver with or without segmental liver transplantation

Locations

Country Name City State
Denmark Nycomed Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary objective is to collect data on efficacy, i.e. intra-operative haemostasis, and safety of TachoSil ® as treatment to control local bleeding in children undergoing surgical resection of the liver with or without segmental transplantation. 7½ months No
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